MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 995

Device Problems Calcified (1077); Gradient Increase (1270); Structural Problem (2506)

Patient Problems Aortic Regurgitation (1716); Calcium Deposits/Calcification (1758); Pulmonary Edema (2020)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

Citation: rheault p et al.Clinical presentation and value of echocardiography in the diagnosis of freestyle aortic bioprosthesis le aflet tears: a retrospective study.The journal of heart valve disease 2016;25:628-633.Earliest date of publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information, it could not be determined whether these observations have been previously reported.(b)(4).

Event Description

Medtronic received information via literature regarding leaflet tears and aortic regurgitation (ar) following bioprosthetic valve implant.All data were collected from a single center between january 1993 and may 2011.The study population included 430 patients (predominantly male; mean age 60 years), all of which were implanted with a medtronic freestyle bioprosthetic valve (serial numbers not provided).Among all patients, one death occurred due to multi-organ failure.This death was not attributed to medtronic product.Among all patients adverse events included: structural valve dysfunction requiring reoperation, dyspnea, mild calcification, elevated gradients, stenosis, and heart failure.The following are 20 patients (specific identifiers or demographics not provided) were summarized with these adverse effects: patient 1: cardiogenic shock, pulmonary edema, leaflet tear, severe ar.Patient 2: pulmonary edema, leaflet tear, severe ar.Patient 3: cardiogenic shock, pulmonary edema, leaflet tear, mild calcification, severe ar.Patient 4: pulmonary edema, leaflet tear , mild calcification, severe ar.Patient 5: pulmonary edema, leaflet tear, severe ar.Patient 6: pulmonary edema, mild calcification, leaflet tear, severe ar.Patient 7: pulmonary edema, leaflets tear, moderate ar.Patient 8: severe ar, leaflet tear.Patient 9: pulmonary edema, leaflet tear, moderate ar.Patient 10: leaflet tear, severe ar.Patient 11: pulmonary edema, leaflet tear, mild calcification, severe ar.Patient 12: leaflet tear, mild calcification, severe ar.Patient 13: leaflet tear, severe ar.Patient 14: leaflets tear, mild calcification, moderate ar.Patient 15: leaflet tear, severe ar.Patient 16: leaflet tear, mild calcification, severe ar.Patient 17: pulmonary edema, leaflet tear, mild calcification, moderate ar.Patient 18: leaflet tear, mild calcification, severe ar.Patient 19: leaflet tear, mild calcification, severe ar.Patient 20: leaflet tear, mild calcification, severe ar.No additional adverse patient effects were reported.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the physician/author stated these adverse events were not related to the freestyle valves, and that the explanted valves are not available for return.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6430022
• MDR Text Key: 70734947
• Report Number: 2025587-2017-00461
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 995
• Device Catalogue Number: 995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 60 YR